The assessment of mucosal healing plays a central role in the treatment course of inflammatory bowel diseases (IBD). Currently, ileocolonoscopy for the colon and terminal ileum and computerized tomography or magnetic resonance for the small bowel, are the standard methods for the evaluation of disease activity.
Achievement of mucosal healing has become an important new treatment goal for IBD patients as recently also supported by regulatory agencies. This more ambitious therapeutic goal was achieved after the introduction of the biological therapies against tumor necrosis factor alpha (TNF-α). Before, only corticosteroids, azathioprine and methotrexate were available to treat Crohn's disease (CD) and the healing rates observed with these agents are poor (Mary et al., Gut, 1989, 30:983-989; Colombel et al., N. Engl., J. Med., 2010, 362:1383-1395; Peyrin-Biroulet et al., Gut, 2014, 63:88-95; Geagan et al., N. Engl. J. Med., 2000; 342:1627-1632).
Several endoscopic activity scoring systems have been developed for CD and ulcerative colitis (UC), but some are complicated, especially for CD. Moreover, frequent endoscopic assessments are expensive and both the procedure as well as the preparation are uncomfortable to the patient. Therefore a high need exists for non-invasive, but accurate surrogate markers for assessment and prediction of mucosal healing. Previous efforts have identified several genetic, blood and fecal markers, but the sensitivity and specificity of the tests are often not sufficient for clinical practice (Daperno et al., J. Crohns Colitis, 2011, 5:484-498).
There is an unmet need in the art for non-invasive methods for predicting the likelihood of mucosal healing patients with inflammatory bowel disease. The present invention satisfies this need and provides related advantages as well.